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Abstract:

A method of repositioning an injection port comprises positioning the
injection port at a first location in a patient's body and extending
fasteners of the injection port to substantially secure the injection
port at the first location. The fasteners are then retracted to
substantially unsecure the injection port from the first location in the
patient's body. The injection port is then moved to a second location in
the patient's body. The fasteners are then re-extended to substantially
secure the injection port at the second location in the patient's body.
The injection port includes a port body. The fasteners are integral with
the port body. The fasteners may be selectively extended and retracted
relative to the port body. For instance, the fasteners may be pivoted
relative to the port body to transition between extended and retracted
positions. The extension and retraction of fasteners may be provided
through a port applier.

Claims:

1. A method of repositioning an injection port, wherein the injection port
comprises a port body and a plurality of fasteners that are integral with
the port body, the method comprising:(a) positioning the injection port
at a first location in a patient's body;(b) extending the fasteners
relative to the port body to substantially secure the injection port at
the first location in the patient's body;(c) retracting the fasteners
relative to the port body while the injection port is at the first
location in the patient's body, to substantially unsecure the injection
port from the first location in the patient's body;(d) moving the
injection port to a second location in the patient's body; and(e)
extending the fasteners relative to the port body to substantially secure
the injection port at the second location in the patient's body.

2. The method of claim 1, wherein the port body is releasably engageable
with a port applier, wherein the act of positioning the injection port is
performed with the port body coupled with the port applier.

3. The method of claim 2, wherein the port applier includes an actuator,
wherein the act of extending the fasteners relative to the port body to
substantially secure the injection port at the first location in the
patient's body comprises actuating the actuator of the port applier.

4. The method of claim 2, wherein the act of retracting the fasteners
relative to the port body is performed with the port body coupled with
the port applier.

5. The method of claim 4, wherein the port applier includes an actuator,
wherein the act of retracting the fasteners relative to the port body
comprises actuating the actuator of the port applier.

6. The method of claim 2, wherein the acts of moving the injection port to
a second location in the patient's body and extending the fasteners
relative to the port body to substantially secure the injection port at
the second location in the patient's body are both performed with the
port body coupled with the port applier.

7. The method of claim 2, further comprising releasing the port body from
the port applier at the first location in the patient's body.

8. The method of claim 7, wherein the acts of extending the fasteners
relative to the port body to substantially secure the injection port at
the first location in the patient's body and releasing the port body from
the port applier at the first location in the patient's body are both
performed substantially simultaneously.

9. A method of repositioning an injection port, wherein the injection port
comprises a port body and a plurality of fasteners that are integral with
the port body, the method comprising:(a) positioning the injection port
adjacent tissue at a first location in a patient's body;(b) extending the
fasteners into the tissue at the first location to substantially secure
the injection port at the first location in the patient's body;(c)
retracting the fasteners from the tissue at the first location to
substantially unsecure the injection port from the first location in the
patient's body;(d) moving the injection port to a position adjacent
tissue at a second location in the patient's body; and(e) extending the
fasteners into the tissue at the second location to substantially secure
the injection port at the second location in the patient's body.

10. The method of claim 9, wherein the fasteners are selectively
extendable relative to the port body.

11. The method of claim 10, wherein the act of extending the fasteners
into the tissue at the first location further comprises extending the
fasteners relative to the port body.

12. The method of claim 9, wherein the fasteners are selectively
retractable relative to the port body.

13. The method of claim 12, wherein the act of retracting the fasteners
from the tissue at the first location further comprises retracting the
fasteners relative to the port body.

14. The method of claim 9, wherein the act of extending the fasteners into
the tissue at the first location comprises pushing the fasteners into the
tissue at the first location;wherein the act of retracting the fasteners
from the tissue at the first location comprises pulling the fasteners
from the tissue at the first location;wherein the act of extending the
fasteners into the tissue at the second location comprises pushing the
fasteners into the tissue at the second location.

15. The method of claim 9, wherein the fasteners are rigid.

16. The method of claim 9, wherein the fasteners are pivotally coupled
with the port body.

17. A method of repositioning an injection port, wherein the injection
port comprises a port body, a plurality of fasteners that are integral
with the port body, and an actuator that is integral with the port body,
the method comprising:(a) positioning the injection port adjacent tissue
at a first location in a patient's body;(b) extending the fasteners into
the tissue at the first location to substantially secure the injection
port at the first location in the patient's body, wherein the act of
extending the fasteners into the tissue at the first location comprises
moving the actuator in a first direction relative to the port body;(c)
retracting the fasteners from the tissue at the first location to
substantially unsecure the injection port from the first location in the
patient's body, wherein the act of retracting the fasteners comprises
moving the actuator in a second direction relative to the port body;(d)
moving the injection port to a position adjacent tissue at a second
location in the patient's body; and(e) extending the fasteners into the
tissue at the second location to substantially secure the injection port
at the second location in the patient's body, wherein the act of
extending the fasteners into the tissue at the second location comprises
moving the actuator in the first direction relative to the port body.

18. The method of claim 17, wherein the actuator is rotatable relative to
the port body.

19. The method of claim 18, wherein the act of moving the actuator in the
first direction relative to the port body comprises rotating the actuator
in a first rotational direction relative to the port body.

20. The method of claim 19, wherein the act of moving the actuator in the
second direction relative to the port body comprises rotating the
actuator in a second rotational direction relative to the port body.

[0002]This application also incorporates by reference the following United
States patent applications, both of which were filed on Dec. 19, 2003:
application Ser. No. 10/741,127, entitled "Subcutaneous Injection Port
for Applied Fasteners," published as U.S. Pub. No. 2005/0131352; and
application Ser. No. 10/741,868, entitled "Subcutaneous Self Attaching
Injection Port with Integral Fasteners," issued as U.S. Pat. No.
7,374,557.

TECHNICAL FIELD

[0003]The present invention relates generally to medical implants and
appliers therefor, and more particularly to an attachment mechanism for
use with a variety of medical implants and appliers for attaching such
medical implants to body tissue. The invention will be disclosed in
connection with, but not limited to, surgically implantable injection
ports and an applier therefor.

BACKGROUND

[0004]Implantable medical devices are typically implanted in a patient to
perform a therapeutic function for that patient. Non-limiting examples of
such devices include pace makers, vascular access ports, injection ports
(such as used with gastric bands) and gastric pacing devices. Such
implants need to be attached, typically subcutaneously, in an appropriate
place in order to function properly. It is desirable that the procedure
to implant such devices be quick, easy and efficient. In many instances
it would be beneficial if the surgeon could remove or reposition the
device quickly, easily and efficiently.

[0005]Injection ports are placed beneath the skin of a body for injecting
fluids into the body, such as for infusing medication, blood draws, and
many other applications, including adjustable gastric bands. Since the
early 1980s, adjustable gastric bands have provided an effective
alternative to gastric bypass and other irreversible surgical weight loss
treatments for the morbidly obese. The gastric band is wrapped around an
upper portion of the patient's stomach, forming a stoma that restricts
food passing from an upper portion to a lower portion of the stomach.
When the stoma is of the appropriate size, food held in the upper portion
of the stomach provides a feeling of fullness that discourages
overeating. However, initial maladjustment or a change in the stomach
over time may lead to a stoma of an inappropriate size, warranting an
adjustment of the gastric band. Otherwise, the patient may suffer
vomiting attacks and discomfort when the stoma is too small to reasonably
pass food. At the other extreme, the stoma may be too large and thus fail
to slow food moving from the upper portion of the stomach, defeating the
purpose altogether for the gastric band.

[0006]In addition to a latched position to set the outer diameter of the
gastric band, adjustability of gastric bands is generally achieved with
an inwardly directed inflatable balloon, similar to a blood pressure
cuff, into which fluid, such as saline, is injected through a fluid
injection port to achieve a desired diameter. Since adjustable gastric
bands may remain in the patient for long periods of time, the fluid
injection port is typically installed subcutaneously to avoid infection,
for instance in front of the sternum. Adjusting the amount of fluid in
the adjustable gastric band is achieved by inserting a Huber needle
through the skin into a silicon septum of the injection port. Once the
needle is removed, the septum seals against the hole by virtue of
compressive load generated by the septum. A flexible conduit communicates
between the injection port and the adjustable gastric band.

[0007]The present invention encompasses an attachment mechanism to secure
an medical implant device to body tissue quickly and easily. The
attachment mechanism may be reversible, allowing the implantable medical
device to be detached quickly and easily for repositioning or removal.
Although standard, commercially available instruments may be used to
actuate the attachment mechanism, the present invention also encompasses
an applier for locating an implantable medical device in the desired
location and quickly and easily actuating the attachment mechanism to
secure the implantable medical device.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008]The accompanying drawings, which are incorporated in and constitute
a part of this specification, illustrate embodiments of the invention,
and, together with the general description of the invention given above,
and the detailed description of the embodiments given below, serve to
explain the principles of the present invention.

[0009]FIG. 1 is a perspective view of an injection port with an attachment
mechanism constructed in accordance with the present invention.

[0010]FIG. 2 is a top view of the injection port of FIG. 1.

[0011]FIG. 3 is a bottom view of the injection port of FIG. 1.

[0012]FIG. 4 is a cross sectional view of the injection port of FIG. 1
taken along line 4-4 of FIG. 3.

[0013]FIG. 5 is an exploded perspective view of the injection port of FIG.
1.

[0014]FIG. 6 is perspective view of the bottom of the injection port of
FIG. 1, showing the attachment mechanism in the retracted position.

[0015]FIG. 7 is a perspective view of the bottom of the injection port of
FIG. 1, similar to FIG. 6, showing the attachment mechanism in the
extended/fired position.

[0016]FIG. 8 is a side cutaway view in partial cross-section illustrating
a fastener of the attachment mechanism in the retracted position.

[0017]FIG. 9 is a side cutaway view in partial cross-section similar to
FIG. 8 illustrating a fastener of the attachment mechanism that is being
advanced by the actuator ring toward the extended/fired position.

[0018]FIG. 10 is a side cutaway view in partial cross-section similar to
FIG. 8 illustrating a fastener of the attachment mechanism in the
extended/fired position.

[0019]FIG. 11 is a side cutaway view in partial cross-section similar to
FIG. 8 illustrating a fastener of the attachment mechanism that is being
advanced by the actuator ring toward the retracted position.

[0020]FIG. 12 is a top view of the injection port of FIG. 1, with the
actuator ring omitted to illustrate the positions of the links when the
fasteners are in the retracted position.

[0021]FIG. 13 is a top view of the injection port of FIG. 1, with the
actuator ring omitted to illustrate the positions of the links when the
fasteners are in the extended/fired position.

[0022]FIG. 14 is an enlarged, fragmentary top view of the visual position
indicator and actuator ring detent system of the attachment mechanism of
FIG. 1, in the retracted position.

[0023]FIG. 15 is an enlarged, fragmentary top view of the visual position
indicator and actuator ring detent system of the attachment mechanism of
FIG. 1 in the extended/fired position.

[0024]FIG. 16 is an enlarged, fragmentary, exploded perspective view of
the fitting and locking connector of the injection port of FIG. 1.

[0025]FIG. 17 is an enlarged, fragmentary partial cross-section view of
the locking connector assembled to the fitting the septum retainer but
not locked in place.

[0026]FIG. 18 is an enlarged, fragmentary partial cross-section view
similar to FIG. 17 showing the locking connector locked in place.

[0027]FIG. 19 is an enlarged perspective view of the safety cap.

[0028]FIG. 20 is a perspective view of an applier constructed to implant
the injection port of FIG. 1.

[0029]FIG. 21 is a exploded, perspective view of the applier of FIG. 20.

[0030]FIG. 22 is a side view of the applier of FIG. 20 with one of the two
body halves showing the internal components in the unapplied,
non-actuated position.

[0031]FIG. 23 is a side view of the applier of FIG. 20 similar to FIG. 22,
showing the internal components in the applied, actuated position.

[0032]FIG. 24 is an enlarged, fragmentary side view of the linear to
rotary cam mechanism of the applier of FIG. 20.

[0033]FIG. 25 is an enlarged top perspective view of the locator of the
applier of FIG. 20.

[0034]FIG. 26 is an enlarged bottom perspective view of the locator and
the port actuator of the applier of FIG. 20.

[0035]FIG. 27 is a partially cut away end view of the locator of the
applier of FIG. 20.

[0036]FIG. 28 is an enlarged, cross sectional view of the injection port
of FIG. 1 retained by the locator of the applier of FIG. 20.

[0037]FIG. 29 is an enlarged, cross-sectional view of the injection port
of FIG. 1 disposed in the locator of the applier of FIG. 20 after the
applier has been actuated to rotate the applier actuator to the deployed
position.

[0038]FIG. 30 is a diagrammatic drawing showing an injection port
connected to an adjustable gastric band wrapped around an upper part of a
stomach.

[0039]Reference will now be made in detail to the present preferred
embodiment of the invention, an example of which is illustrated in the
accompanying drawings.

DETAILED DESCRIPTION

[0040]In the following description, like reference characters designate
like or corresponding parts throughout the several views. Also, in the
following description, it is to be understood that terms such as front,
back, inside, outside, and the like are words of convenience and are not
to be construed as limiting terms. Terminology used in this patent is not
meant to be limiting insofar as devices described herein, or portions
thereof, may be attached or utilized in other orientations. Referring in
more detail to the drawings, an embodiment of the invention will now be
described.

[0041]Referring to FIGS. 1-5, there is shown an implantable medical
device, more specifically an injection port, generally indicated at 2,
which embodies an attachment mechanism constructed in accordance with the
present invention. Although the attachment mechanism is illustrated in
the figures as being embodied with injection port 2, the attachment
mechanism may be used with any implantable medical device for which it is
suited, including by way of example only pace makers, vascular access
ports, injection ports (such as used with gastric bands) and gastric
pacing devices.

[0042]Injection port 2 includes septum retainer 4, septum 6 and port body
8. Injection port 2, with the integrally constructed attachment
mechanism, also includes one or more fasteners 10, actuator 12 and a
plurality of link members 14.

[0043]As seen in FIG. 4, septum 6, which may be made of any biocompatible
material such as silicone, is disposed partially within internal cavity
16 of septum retainer 4, adjacent annular flat 18. Septum retainer 4,
port body 8, and actuator 12 may be made of any suitable biocompatible
material having sufficient stiffness and strength, such as
polyetheretherketon (known as PEEK). Fasteners 10 and link members 14 may
be made of any suitable biocompatible material, such as stainless steel.

[0044]Port body 8 includes annular rim 20, which engages the upper surface
of septum 6 about an annular portion. Port body 8 is retained to septum
retainer 4 by a plurality of pins 22 which are disposed through
respective holes 24 formed in recesses 24a in port body 8 and which
extend inwardly into respective recesses 26 formed about the bottom
periphery of septum retainer 4. Pins 22 may be made of any suitable
biocompatible material, such as stainless steel.

[0045]The uncompressed height of septum 6 is approximately 5 mm around the
outer diameter and the uncompressed diameter is approximately 18 mm. The
exposed diameter for access to reservoir 20 is approximately 14 mm The
distance between the lower surface of annular rim 20 and annular flat 18
is approximately 4 mm, such that septum 6 is compressed approximately 20%
to be adequately self healing to maintain a fluid tight system under
pressure and still allow a low profile.

[0046]Plate 28 is disposed in recess 16a formed in the bottom of septum
retainer 4, underlying septum 6 and fluid chamber or reservoir 30. As
seen in FIG. 4, plate 28 does not contact sidewall 16b. In the embodiment
depicted, plate 28 is metallic, such as stainless steel. When a needle is
inserted through septum 6 to introduce or withdraw fluid from fluid
chamber 30, such as in order to adjust the size of an adjustable gastric
band, metallic plate 28 will protect septum retainer 4 from puncture and
provide tactile feedback to the surgeon through the needle indicating
that the needle has bottomed in reservoir 30. Plate 28 may be secured to
septum retainer 4 in any suitable manner. In the embodiment depicted,
plate 28 is held in place by retaining lip 4a extending over the
periphery of plate 28 as best seen in FIGS. 4, 28 and 29. Initially,
retaining lip 4a extends upwardly as an annular lip, providing clearance
for insertion of plate 28 into the recess at the bottom of septum
retainer 4, and retaining lip 4a is then rolled or otherwise deformed to
overlie at least a portion of the periphery of plate 28 thereby retaining
plate 28. In the embodiment depicted the diameter of recess 16a is
smaller than the diameter of sidewall 16b, providing room to form the
annular lip and to deform it into retaining lip 4a. Plate 28 could be
insert molded, with retaining lip 4a molded as illustrated.

[0047]Septum retainer 4 includes passageway 32, in fluid communication
with fluid chamber 30, which is defined by fitting 34 extending from the
periphery adjacent the bottom of retainer 4. Tube 36, which in the
embodiment depicted, leads to an adjustable gastric band (not shown), is
connected to fitting 34, being compressingly urged against annular rib 38
by connector 40, which is disposed about tube 36 and secured to port body
8 as described below. Sleeve 42 is disposed about tube 36, secured to
connector 40 by annular ribs 44. Sleeve 42 relieves strain on tube 36,
preventing tube 36 from kinking when loaded laterally.

[0048]Actuator 12 is secured to port body 8. Although in the embodiment
depicted actuator 12 is illustrated as an annular ring rotatably
supported by port body 8, actuator 12 may be any suitable configuration
and supported in any suitable manner to permit actuator 12 to function to
move fasteners 10 between and including deployed and undeployed
positions. As seen in FIG. 5, port body 8 includes a plurality of
downwardly and outwardly extending tabs 46. In the embodiment depicted,
there are four equally spaced tabs 46. Actuator 12 includes an equal
number of corresponding recesses 48, each having arcuate bottom 50. To
assemble actuator 12 to port body 8, recesses 48 are aligned with tabs
46, and pushed down, temporarily deflecting tabs 46 inwardly until tabs
46 reach recesses 48 and move outwardly to dispose lower edges 46a in
recesses 48 such that actuator is retained thereby. The lengths of tabs
46 and depth of recesses 48 allow some axial end play between actuator 12
and port body 8, as will be described below.

[0049]Actuator 12 may rotate generally about the central axis of port body
8. In the embodiment depicted, actuator 12 may rotate through an angle of
about 40 degrees, although any suitable angle may be used. In the
embodiment depicted, when actuator 12 is rotated in the deploying
direction, causing fasteners 10 to move to the deployed position,
rotation of actuator 12 beyond the fully deployed position is limited by
end 48c contacting tab 46.

[0050]A detent system is formed by a pair of spaced apart raised detent
ribs 48a, 48b extending inwardly from the wall of each recess 48, and a
corresponding raised rib 46b extending outwardly from tab 46. The detent
system assists in preventing actuator 12 from rotation and fasteners 10
from moving out of fully retracted or fully extended fired states under
vibration or incidental loads, as described below.

[0051]Actuator 12 includes a plurality of spaced apart openings or slots
54, which may be engaged by any suitable instrument to transmit the
necessary torque to actuator 12 to extend fasteners 10 to the actuated
position. Slots 54 are configured to be engaged by commercially available
instruments, rectangular in the embodiment depicted, or by the dedicated
applier described below. Port body 8 includes a plurality of recesses 56
disposed about its lower periphery which are configured to cooperate with
the dedicated applier as described below.

[0052]Referring also to FIGS. 6 and 7, septum retainer 4 includes a
plurality of locating tabs 58 extending outwardly from adjacent the
bottom periphery of septum retainer 4. Locating tab 58a may be integral
with fitting 34. Tabs 58 and 58a are located in respective
complementarily shaped recesses 60 formed in the inner surface of port
body 8, aligning septum retainer 4 properly with port body 8.

[0053]FIG. 6 illustrates fasteners 10 in the retracted position. As can be
seen, fasteners 10 are disposed in respective recesses or slots 60 formed
in port body 8. FIG. 7 illustrates fasteners 10 in the extended, or
fired, position, extending from slots 60. Rotation of actuator 12 moves
fasteners 10 from the retracted position to the extended position.

[0054]FIGS. 8-11 are a series of figures illustrating the operation of
actuator 12 and one of the plurality of fasteners 10, it being understood
that the operation on one of fasteners 10 may be the same as for all
fasteners 10, which may, in one embodiment, be moved from a deployed
position to an undeployed position simultaneously. FIG. 8 illustrates
fastener 10 in a fully retracted state, the undeployed position, disposed
completely within slot 62 such that sharp tip 64 is not exposed. This
prevents tip 64 from accidentally sticking the surgeon or penetrating any
object. Actuator 12 is illustrated rotated counter clockwise as far as
permitted by recesses 48 and tabs 46. In this position, ribs 46b are
disposed clockwise of ribs 48b, as seen in FIG. 14. First ends 14a of
link members 14 are rotatably carried by actuator 12, spaced apart at
positions corresponding to the positions of fasteners 10. Second ends 14b
are disposed within openings 66 of fasteners 10.

[0055]To actuate the attachment mechanism, integral actuator 12 is rotated
in a deploying direction, which in one embodiment as depicted is
clockwise (any suitable direction configured to actuate the attachment
mechanism may be used), and rib 46b passes rib 48b, which may produce an
audible signal in addition to a tactile signal to the surgeon. Second end
14b of link member 14 is free to move within slot 66 during actuation, as
the force that rotates fastener 10 into the extended position is
transmitted to fastener 10 through the interaction between cam surface 68
of fastener 10 and actuating cam surface 70 of actuator 12. As actuator
12 rotates clockwise, actuating cam surface 70 engages and pushes against
cam surface 68, rotating fastener 10 about pivot pin 22. The majority of
the force from actuating cam surface 70 acts tangentially on cam surface
68, off center relative to pivot pin 22, causing fastener 10 to rotate.
During actuation, end 14b of link member 14 remains free to move within
slot 66, applying no driving force to rotate fastener 10.

[0056]In FIG. 9, fastener 10 is rotated about half way though its range of
rotation, about 90 degrees as a result of the clockwise rotation of
actuator 12. As actuator 12 is rotated clockwise, the force between
actuator cam surface 70 and cam surface 68 causes actuator 12 to move
upward slightly as allowed by the tolerancing of the components. As
actuator 12 is rotated further clockwise from the position shown in FIG.
9, actuator cam surface 70 continues to engage and push against cam
surface 68, rotating fastener 10 further counterclockwise.

[0057]In FIG. 10, actuator 12 is rotated clockwise to its fullest extent,
with rib 46b having been urged past detent rib 48a (see FIG. 15). In this
position, fastener 10 has rotated to its fullest extent, almost 180
degrees in the embodiment illustrated, with tip 64 disposed within recess
62. In this position, actuator cam surface 70 is over center, and
actuator 12 is resistant to being back driven by an undeploying force
imparted to fastener 10 as cam surface 68 acts against actuator cam
surface 70 in a direction that tends to push actuator 12 up instead of
rotating actuator 12. The distal end portion of fastener 10 is configured
essentially as a beam, depicted as having a generally rectangular cross
section along its length, tapering to sharp tip 64. With fastener 10
extending approximately 180 degrees in the fully extended state, the
deployed position, forces which might act on fasteners 10 tend to act
through the pivot axis defined by pivot pin 22, instead of rotating
fasteners 10. It is noted that although pin 22 is illustrated as being a
separate piece from fastener 10, the two may be integral or even of
unitary construction.

[0058]If it is desirable to retract fasteners 10, such as to remove or
reposition the implanted device, actuator 12 may be rotated in an
undeploying direction, counterclockwise in one embodiment depicted.
Starting with the position of actuator 12 shown in FIG. 10, actuator 12
may be rotated counterclockwise, with actuator cam surface 70 sliding
against cam surface 68, without rotating fastener 10. In the embodiment
depicted, continued counterclockwise rotation of actuator 12 moves cam
surface 70 out of contact with cam surface 68, with no substantial
rotating force being exerted on fastener 10 until second end 14b of link
member reaches a location in slot 66, such as at one end of slot 66, at
which link member 14 begins pulling against slot 66 causing fastener 10
to rotate and begin to retract.

[0059]As seen in FIG. 11, actuator 12 has been advanced counterclockwise
compared to the position shown in FIG. 10, and fastener 10 is rotated
approximately halfway through its range. As can be seen by comparing FIG.
9 to FIG. 11, actuator 12 is in different positions with fastener 10 in
the same position, in dependence upon whether the attachment mechanism is
being actuated or deactuated (retracted). This results from the lost
motion that results when link member 14 is pulling on slot 66 in
comparison to actuator cam surface 70 pushing directly on cam surface 68.
To retract fasteners 10 fully, actuator 12 is rotated until detent rib
46b snaps past detent rib 48b.

[0060]Referring to FIG. 8, when fasteners 10 reach the fully undeployed
position tip 64 may be disposed fully in slot or recess 62. Further
undeploying rotation of actuator 12 is prevented by link member 14 which
is prevented from further movement by fastener 10.

[0061]Referring to FIGS. 2 and 3, actuator 12 includes openings 52a formed
therethrough, which align with corresponding openings 52b formed in port
body 8 when actuator is in the undeployed position. Openings 52a and 52b
may be used by the surgeon to suture injection port 2 if the integral
attachment mechanism is not used.

[0062]Referring to FIGS. 12 and 13, the attachment mechanism is shown
without actuator 12. Link members 14 are shown in their actual positions
when first ends 14a are supported by actuator 12, in the deployed and in
the undeployed states.

[0063]Referring to FIGS. 14 and 15, there is illustrated a top view of the
visual position indicator and a portion of the actuator ring detent
system of the attachment mechanism as embodied in injection port 2. In
FIG. 14, the attachment mechanism is in the retracted, undeployed state
or position. In this position, detent rib 46b is clockwise of detent rib
48b, and thus in the undeployed detent position. In FIG. 15, the
attachment mechanism is in the actuated or deployed position. In this
position, detent rib 46b is counterclockwise of detent rib 48b, and thus
in the deployed detent position.

[0064]FIGS. 14 and 15 illustrate a visual indicator of the state of the
attachment mechanism. As seen in FIG. 14, indicia may be utilized, such
as an unlocked lock icon 72 and a locked lock icon 74 molded integral
with actuator ring 12. Any suitable graphic indicator may be used, and
may be printed on or otherwise applied in a suitable manner. Port body 8
may include indicator 76 to provide a reference point for the movable
indicia. Arrow 78 may be included to indicate the bidirectional motion of
actuator 12.

[0065]FIGS. 16-18 illustrate the locking connection between connector 40
and port body 8. FIG. 16 is an exploded perspective view showing fitting
34 partially surrounded by extension 78. FIG. 17 shows extension 78 in
cross-section, with connector 40 generally disposed about fitting 34 and
tube 36 aligned in circumferential slot 78c of extension 78. Connector 40
includes a pair of tabs 40a, 40b, extending outwardly therefrom. To
assemble, connector 40 is guided along tube 36 and fitting 34, with tabs
40a and 40b aligned with openings 78a and 78b of extension 78. With tabs
40a and 40b aligned with circumferential slot 78c, connector 40 is
rotated to lock it in place. During rotation, detent edge 78d creates
interference opposing the rotation of tab 40a, but is dimensioned to
allow tab 40a to be rotated past, to the locked position seen in FIG. 18.

[0066]FIG. 19 illustrates safety cap 80 which may be removably secured to
the bottom of injection port 2 to cover fasteners 10 to protect users
from accidental exposure to sharp tips 64 while handling injection port
2. Safety cap 80 includes body 82 with annular rim 84 and raised center
86 defining annular recess 88. Safety cap 80 may be oriented and retained
to injection port through any suitable configuration. As depicted, body
82 includes a plurality of arcuate retention tabs 90 extending upwardly
from raised center 86. Arcuate retention tabs 90 are shaped
complementarily to corresponding arcuate slots 92, best seen in FIGS. 3,
6 and 7, and may have ribs as shown. Safety cap 80 is secured to
injection port 2 by inserting arcuate retention tabs 90 into arcuate
slots 92, which are sized to retain tabs 90. Fasteners 10 are thus
aligned with annular recess 88, which is sized to allow fasteners 10 to
be extended without contacting safety cap 80. As depicted, since arcuate
retention tabs 90 and arcuate slots 92 are respectively the same size and
equally spaced, safety cap 80 is not indexed to a particular position,
and may be secured to injection port 2 in four different positions.
Safety cap 80 includes pull tab 94 with raised a plurality of ribs 96 to
provide a better gripping surface. Although pull tab 94 may be oriented
in any suitable orientation, in the embodiment, the relative position
between pull tab 94 and arcuate retention tabs 90 locates pull tab at 45
degrees to the direction of connector 40. Tabs 90 and slots 92 may be of
any suitable shape.

[0067]As mentioned previously, the attachment mechanism may be actuated by
engaging slots 54 with commercially available instruments or by a
dedicated applier. FIG. 20 illustrates applier, generally indicated at
100, which is configured to position, actuate, deactuate, remove or
reposition injection port 2. It is noted that the practice of aspects of
the present invention as applied to an applier is not limited to the
specific applier embodiment depicted herein.

[0068]As shown in FIG. 20, applier 100 includes body 102, locator 104,
actuator 106 and safety switch 108. As will be described below, injection
port 2 may be assembled to locator 104, with extension 78 and tab 96
disposed in alignment slots 110 and 112. Locator 104 is angled relative
to body 102, allowing for easier and better visualization of injection
port 2 during implantation. In the embodiment depicted, the angle is 20
degrees and the shaft portion of body 102 is 10 cm.

[0069]Referring to FIG. 21, body 102 includes first and second halves 102a
and 102b assembled to each other to contain the internal components.
Except for locating pins 202, pivot pins 114 and ship laps, body halves
102a and 102b are substantially similar to each other. Locating pins 202,
illustrated as extending from body half 102a, fit into respective
complementarily shaped openings (not illustrated) on body half 102b. The
engagement of the plurality of locating pins 202 in the openings is
sufficient to hold body halves 102a and 102b together. Pins 202 may
alternatively extend from body half 102b with the openings carried by
body half 102a. Any suitable configuration may be used to assemble and
secure body halves 102a and 102b together.

[0070]Actuator 106 includes first and second halves 106a and 106b.
Locating pins 204, illustrated as extending from actuator half 106a, fit
into respective complementarily shaped openings (not illustrated) on
actuator half 106b. Pins 204 may alternatively extend from actuator half
106b with the openings carried by actuator half 106a. Any suitable
configuration may be used to assemble and secure actuator halves 106a and
106b together. Body half 102b includes pivot pin 114b which rotatably
supports actuator 106 at one end, extending through pivot holes 116a and
116b into opening 114a. Body half 102a includes pivot pin 118b (see FIG.
22) which rotatably supports safety switch 108. Body halves 102a and
102b, locator 104, actuator halves 106a and 106b, and safety switch 108
may be made of any biocompatible material such as polycarbonate.

[0071]Referring to FIGS. 21-24, applier 100 includes cam 120, drive shaft
122 with flexible shaft 124, drive shaft pin 126, cam return spring 128,
safety biasing spring 130, and actuator 132. Actuator 132 is configured
to effect the deployment or undeployment of the attachment mechanism of
the medical implant. Cam 120 includes shaft 134 and cam collar 136. The
upper end of shaft 134 has a "T" configuration terminating in cross
member 138. Cam collar 136 defines a hollow interior and a pair of spaced
apart, complementarily shaped cam tracks 140a and 140b formed on opposite
sides of cam collar 136. Upper end 122a of drive shaft 122 is disposed
partially within the hollow interior defined by cam collar 136, captured
therein by drive shaft pin 126. Drive shaft pin 126 is sized such that
each end is located within a respective cam track 140a, 140b. The length
of the hollow interior allows upper end 122a to reciprocate therein, with
cam tracks 140a and 140b imparting rotation to drive shaft 122 through
drive shaft pin 126 during reciprocation. Cam 120, drive shaft 122 and
actuator 132 may be made of any suitable material having sufficient
stiffness and strength. In the embodiment depicted, cam 120 and actuator
132 are made of a liquid crystal polymer such as Vectra® LCP, and
drive shaft 122 is made of a PPE+PS such as Noryl®. Drive shaft pin
126 and cam return spring 128 may be made of any suitable material, such
as stainless steel.

[0072]Cam 120 is retained between body portions 102a and 102b, and in one
embodiment, such as that depicted can reciprocate. Cam collar 136 has
spaced apart, generally flat outer surfaces 142a and 142b tracks through
which 140a and 140b are formed. These surfaces 140a and 140b are disposed
between guide walls 144a and 144b formed in body portions 102a and 102b.
Cam collar 136 also includes oppositely facing channels 146a and 146b
(see FIG. 23), which are guided for axial reciprocation by guides 148a
and 148b (not illustrated) formed in body portions 102a and 102b,
respectively. The upper end of shaft 134 and cross member 138 are
disposed sandwiched between actuator halves 106a and 106b. Each actuator
half 106a, 106b, includes a cam track 150 defined by a pair of spaced
apart walls 150a and 150b extending from the interior surfaces of
actuator halves 106a and 106b. Cam track 150 is configured to receive and
guide cross member 138 as actuator 106 is rotated about pin 114, forcing
cam 120 to advance linearly downwardly into body 102.

[0074]Flexible shaft 124 is supported by a plurality of ribs 156, formed
in each body half 102a, 102b, which support the bend in flexible shaft
124 that permits the rotary motion to be transferred to actuator 132
which is disposed at an angle relative to the shaft of body 102. Flexible
shaft 124 may be made of any suitable biocompatible material, such as
stainless steel. In an embodiment depicted, flexible shaft 124 has a
stranded construction, with a center core having multiple layers of wire
wrapped thereabout. Ends 124a and 124b of flexible shaft 124 may be
attached to end 122b and actuator 132, respectively, in any suitable
manner which sufficiently limits rotational end play to prevent or
minimize lost rotational motion. In an embodiment depicted, end 124a was
overmolded into end 122b, and end 124b was press fit into actuator 132.
Alternatively, end 124a could be press fit into end 122b, and end 124b
overmolded into actuator 132, both could be press fit, or both could be
overmolded (with a corresponding change to the configuration of locator
104 to allow assembly.

[0075]Referring to FIGS. 21-25, actuator 132 includes disc shaped member
158 and shaft 160 extending upwardly therefrom. The upper end of shaft
160 includes a pair of outwardly extending tabs 162a and 162b. Locator
104 includes hub 164 defining bore 166 therethrough. Bore 166 is shaped
to receive and rotatably support shaft 160, and includes two outwardly
extending arcuate recesses 168a and 168b configured to provide assembly
clearance for tabs 162a and 162b, allowing hub 164 to be inserted into
bore 166. The lengths of shaft 160 and hub 164 are sized such that tabs
162a and 162b are located above upper surface 164a of hub 164, allowing
rotation of actuator 132 while retaining it axially relative to hub 164.
Stops 170 and 170b extend upwardly from upper surface 164a, limiting the
rotation of actuator 132. Bore 166 defines a central axis of locator 104
about which actuator 132 is rotated. The central axis of locator 104 is
disposed at an angle to the axis of the shaft portion of body 102, as
previously mentioned.

[0077]Referring also to FIGS. 26 and 27, disc shaped member 158 of
actuator 132 is seen disposed within locator 104. Actuator 132 includes a
pair of spaced apart posts 176a and 176b, extending from adjacent
periphery 158a of member 158. Posts 176a and 176b are shaped
complementarily with openings 54. In the embodiment depicted, the distal
ends of posts 176a and 167b are tapered to assist in guiding posts 176a
and 176b into openings 54. Any suitable configuration may be utilized to
create releasable contact between actuator 132 and actuator 12 capable of
actuating actuator 12.

[0078]Disc shaped member 158 also includes a pair of spaced apart cams
178a and 178b which extend outwardly and upwardly from periphery 158a of
member 158. FIG. 27 illustrates cam 178a at a cross-section taken near
the bottom surface of member 158. Cams 178a and 178b include ramps 180a
and 180b which start at periphery 158a and lead out to surfaces 182a and
182b, respectively. Each surface 182a, 182b is arcuate, shown in the
embodiment depicted as generally having a constant radius.

[0079]In the embodiment depicted, locator 104 includes a pair of spaced
apart cantilever arms 184a and 184b, each having rib 186a and 186b,
respectively. For clarity, FIG. 27 illustrates arm 184a in cross-section
taken through rib 186a, at the same level as for cam 178a. At their
distal ends, arms 184a and 184b include respective inwardly extending
flanges 188a and 188b. Flanges 188a and 188b are shaped complementarily
to recesses 56 on port body 8, configured to engage ledges 56a when
injection port 2 is retained by locator 104.

[0080]In the embodiment depicted, in the non-actuated state, posts 176a
and 176b are generally aligned with arms 184a and 184b, respectively,
although posts 176a and 176b may be at any position that corresponds to
position of the actuating feature of actuator 12, which in the embodiment
depicted is openings 54. As actuator 106 is depressed, actuator 132
rotates (counterclockwise in the embodiment depicted when viewed from the
bottom), advancing cams 178a and 178b such that ramps 180a and 180b
contact ribs 186a and 186b, respectively, deflecting arms 184a and 184b
outwardly. When surfaces 182a and 182b engage ribs 186a and 186b, arms
184a and 184b are deflected a distance sufficient to move flanges 188a
and 188b to a position where they no longer extend into recesses 56 or
contact ledges 56a, thus releasing injection port 2 from locator 104.

[0082]Referring also to FIGS. 20 and 22, to insert injection port 2 into
locator 104, actuator 106 is oriented in the undeployed position so that
actuator 132 is in the undeployed position. Actuator 12 is oriented in
the undeployed position, and inserted into locator 104, with extension
housing 78 and tab 96 disposed in slots 110 and 112, respectively.

[0083]Actuator 106 may, as illustrated in FIG. 20, include a visual
indicator to indicate whether actuator 106 is fully in the undeployed
state, such as unlocked lock icon 190, and indicia to indicate whether
actuator 106 is in the deployed state, such as locked lock icon 192. Such
visual indication may be include by any suitable manner, such as by
molding integral with actuator 106, applying as a adhesive film or such,
or printing directly on actuator 106. With the indicator illustrated,
unlocked lock icon 190 is visible adjacent the upper edge of body 102,
although other configurations of indication may be utilized, such as a
window or such formed in body 102 to reveal the indicia.

[0084]To use, locator 104 and a portion of 102, if necessary, is inserted
through an incision by the surgeon and located in the desired position
adjacent the body tissue to which the medical implant (which in the
embodiment depicted is an injection port 2) is to be attached. The angle
between locator 104 and body 102 allows the surgeon to visualize the site
directly. With injection port 2 in position, the one or more fasteners 10
are moved from the undeployed position to the deployed position in an
annular path to engage the tissue. Fasteners 10 allow injection port 2 to
be secured to the tissue with a retention strength equal to or greater
than when secured with sutures. Safety switch 108 is rotated about pivot
pin 118, withdrawing lockout tab 194 from lower opening 196, allowing
actuator 106 to be rotated about pivot pin 114. This action causes cam
track 150 to move cross member 138 downward, causing cam collar 136 to
rotate drive shaft 122, thereby rotating actuator 132 relative to locator
104.

[0086]Once actuator 106 reaches the deployed position, lockout tab 194 is
urged into upper opening 198, retaining actuator 106 in the deployed
position. In the embodiment depicted, spring 130 biases lockout tab 194
sufficiently to produce sound as lockout tab 194 snaps into upper opening
198, providing an audible signal that actuator 106, and therefore
actuator 12 and fasteners 10 are deployed fully. As illustrated in FIG.
29, with actuator 106 in the deployed position, actuator 12 has been
rotated and fasteners 10 are in the deployed position having penetrated
the body tissue, such as the rectus sheath. Cams 178a and 178b have been
rotated to a position where surfaces 182a and 182b are adjacent ribs 186a
and 186b, with arms 184a and 184b deflected outwardly such that flanges
188a and 188b are not disposed in recesses 56 and not engaging ledges
56a. With injection port 2 secured to the body tissue, and released from
locator 104, the surgeon may withdraw locator 104, leaving injection port
2 in place. If a visual indicator of the state of the attachment
mechanism is included with the implant, the surgeon can tell whether the
attachment mechanism is fully deployed.

[0087]The attachment mechanism embodied in injection port 2 is configured
to be reversible so that the medical implant, injection port 2, may be
moved, such as to reposition it or remove it from the patient. To do so,
with actuator 106 in the deployed position, locator 104 is placed over
injection port 2, locating extension 78 and tab 96 in slots 110 and 112
so that posts 176a and 176b are engaged with recesses 54. Safety switch
108 is rotated to withdraw lockout tab 194 from upper opening 198, while
the surgeon pulls up on extension 200 of actuator 106. Although cam
return spring 128 urges cam collar 136 upwardly, extension 200 allows an
additional return force to be applied. As cross member 138 is pulled up
by cam track 150, actuator 132 rotates actuator 12, moving fasteners 10
from the deployed position to the undeployed position simultaneously,
while cams 178a and 178b disengage from ribs 186a and 186b, allowing
flanges 188a and 188b to engage recess 56 and ledge 56a so as to retain
injection port 2 in locator 104. When actuator 106 has been moved to the
undeployed position, lockout tab 194 snaps into lower opening 196,
generating an audible signal that actuator 106 is undeployed fully, and
injection port 2 is detached from the body tissue and may be relocated or
removed.

[0088]In FIG. 30, adjustable gastric band 210 is shown wrapped around an
upper portion of stomach 212, kept in place by attaching the two ends
together and extending portion 214 of the stomach 212 over adjustable
gastric band 210 by suturing portion 214 to the stomach. One end of
flexible conduit 216 is in fluid communication with the internal cavity
of the balloon (not shown), with the other end being in fluid
communication with an internal cavity of injection port 218. At the time
adjustable gastric band 210 is implanted around a portion of the stomach,
remote injection port 218 is also implanted at a suitable location,
usually within the rectus sheaths, for transcutaneous access via a Huber
needle.

[0089]In summary, numerous benefits have been described which result from
employing the concepts of the invention. The foregoing description of one
or more embodiments of the invention has been presented for purposes of
illustration and description. It is not intended to be exhaustive or to
limit the invention to the precise form disclosed. Modifications or
variations are possible in light of the above teachings. The one or more
embodiments were chosen and described in order to illustrate the
principles of the invention and its practical application to thereby
enable one of ordinary skill in the art to utilize the invention in
various embodiments and with various modifications as are suited to the
particular use contemplated. It is intended that the scope of the
invention be defined by the claims submitted herewith.